Rectal Cancer, Total Mesorectal Excision, Laser Speckle Contrast Imaging, Indocyanine Green (ICG), Optical Imaging
Conditions
Keywords
Laser speckle contrast imaging, Rectal cancer, Total Mesorectal Excision, Indocyanine Green Fluorescent Imaging
Brief summary
This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.
Interventions
Investigated device: PerfusiX-Imaging, LIMIS Development B.V., The Netherlands ICG-FI: Verdye, 0.2 mg/kg, Firefly® fluorescence imaging PerfusiX-Imaging is used Intracorporally prior to anal specimen transection, extracoporally prior to oral speciamen transection, intracorporally assessing the free bowel ends prior to anastomotic formation. ICG-FI is applied intracorporally assessing the free bowel ends prior to anastomotic formation. Diagnostic imaging: All participants undergo computed tomography with intravenous contrast and a rectal contrast enema.
Sponsors
University of Aarhus
Gødstrup Hospital
Vejle Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
This is an open-label trial. Participants, surgeons, and other study personnel are aware of the study procedures. However, the LSCI measurements are not available to the surgeons during the surgical procedure and are only revealed after completion of the surgery. Therefore, the LSCI measurements cannot influence the surgeons' intraoperative decision-making regarding creation of the rectal anastomosis.
Intervention model description
The primary objective of this clinical investigation is to assess the feasibility of performing laparoscopic laser speckle contrast imaging (LSCI) measurements of intestinal perfusion during rectal cancer surgery. Feasibility will be evaluated in terms of technical feasibility, usability and acceptability among surgeons, and potential influence on surgical decision-making. Secondary objectives include comparison of LSCI with indocyanine green fluorescence imaging, assessment of quantitative perfusion measurements, and exploration of associations between perfusion measurements and postoperative outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Rectal cancer * Surgical strategy either partial or total mesorectal excision * Able to provide informed consent
Exclusion criteria
\- Allergy to iodine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging | Intraoperatively | Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation. Unit: Percentage of participants with succesful assessment |
| Surgeon-reported acceptability of PerfusiX-Imaging | intraoperatively | Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if \>80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. Unit: Percentage of surgeons with a positive evaluation |
| Potential impact of PerfusiX-Imaging on surgical decision making | Intraoperatively | The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm. Unit: milimetres (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI | Immediately after surgery | Surgeons will assess the acceptability and performance of PerfusiX-Imaging and ICG-FI using a predefined Likert-scale questionnaire. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. The proportion of surgeons providing a positive evaluation of PerfusiX-Imaging will be compared with the proportion providing a positive evaluation on ICG-FI. Unit of measure: Proportion of surgeons |
| Absolute intestinal microcirculation | Intraoperatively | Intestinal microcirculation will be quantified using laser speckle contrast imaging (LSCI). Absolute microcirculation will be expressed as the mean laser speckle perfusion unit (LSPU) value obtained from a predefined region of interest (ROI) close to the intestinal anastomotic line. Unit of measure: Laser speckle perfusion units, LSPU |
| Relative intestinal microcirculation | Intraoperatively | Relative intestinal microcirculation will be calculated by normalizing the mean LSPU value from a region of interest to the mean LSPU value obtained from a reference region on the intestines: Unit of measure: Percentage (%): measurement/control\*100 |
| Length of initial hospital stay after surgery | From the end of surgery until initial hospital discharge, up to 30 days after surgery | Length of initial hospital stay after surgery will be calculated as the number of hours from the end of surgery until initial discharge from hospital. The association between length of initial hospital stay after surgery and quantitative measurements of intestinal microcirculation will be explored. Unit of measure: Hours |
| Severity of postoperative complications according to the Clavien-Dindo classification | 30 days after surgery | Postoperative complications occuring within 30 days after surgery will be graded according to the Clavien-Dindo classification (Grade I-V). The asociation between quatitative measurements of intestinal microcirculation and the severity of postoperative complications will be explored. Units of measure: Clavien-Dindo |
| Surgical complications within 30 days after surgery | 30 days after surgery | The occurence of surgical complications within 30 days after surgery will be recorded. Surgical complications include bleeding, fascial dehiscence, postoperative ileus, surgical site infection, intraabdominal abscess, stoma related complications. The association between surgical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored. Units of measure: Participants with one or more surgical complications |
| Medical complications within 30 days after surgery | 30 days after surgery | The occurence of medical complications within 30 days after surgery will be recorded. Medical complicatinos include stroke, myocardial infarction, heart failure, pneumonia, aspiration, respiratory failure, deep vein thrombosis, acute arterial insufficiency and sepsis. The association between medical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored Units of measure: Participants with one or more medical complications |
| Anastomotic leakage within 30 days of surgery | 30 days after surgery | Occurrence of anastomotic leakage within 30 days after surgery will be recorded as a binary outcome (yes/no). The association between anastomotic leakage and quantitative measurements of intestinal microcirculation will be explored. Units of measure: Participants with anastomotic leakage |
Countries
Denmark
Contacts
CONTACTMai-Britt W. Ørntoft, MD, Ph.D, Ass. Professor
Outcome results
None listed